Applying Quality Risk Management (QRM) (T42)

Quality Risk Management (QRM) principles require the evaluation of risk to quality based on scientific knowledge and the protection of the patient. Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9. The application and the complexity of risk management tools need to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny, and the overall approach should be defined in a formal Risk Management Plan (RMP). To date the application of ICHQ9 is evident in risk based approaches to commissioning and qualification, but to a lesser extent holistically throughout the product lifecycle.

Through interactive workshops, this course will explain and apply the key principles of QRM programs that need to include Quality Systems elements (ICH Q10) within the product/system lifecycle, including but not limited to:

All processes, tests, systems, equipment and facilities related to the clinical and commercial manufacturing of products

New product and process development and transfer

Change control

Vendor selection and qualification

Supplier management

Corrective and preventive actions

Complaint handling

Deviations

Inspections, both internal and external

Training

New regulatory requirements

Trends from quality indicators, periodic quality and product reviews

New business strategies that may have a critical impact on the quality system

Stability monitoring

Validation approach

This course will dive into specific strategies and discussions on important elements of QRM such as defining the criteria for risk ratings and risk mitigation requirements; the importance and necessity of tracking and monitoring the outputs of risk assessments; and how to use risk assessment outputs for trending and process improvement.

NOTE: It is strongly recommended that participants be familiar with basic concepts of ICH Q8(R2), ICH Q9 and ICH Q10 and have a fundamental understanding of risk-based C&Q prior to attending this course.

Webinar

We recommend participants complete the primer course webinar that provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10, and the basic concepts of risk-based commissioning and qualification to provide a foundation to the QRM process.

This course includes the primer webinar. Access information will be provided via email one week prior to the start of the training event.

Course Modules

Day 1

History and Introduction to Quality Risk Management

Regulatory Overview

Risk Management Plan Development and Implementation

Risk Management Roles and Responsibilities

Breakout – Development of a Risk Management Plan Outline

The QRM Process

Risk Identification

Risk Assessment

Risk Evaluation

Risk Control (Reduction and Acceptance)

Ranking and Trending

Reports and Outputs

Breakout – What Your Company Needs to Establish a Formal QRM Program

QRM Tool

Breakout – What tool is suitable and when?

Day 2

Review of Day 1

QRM Tools, continued

Breakout – Practice Risk Assessment

Risk decision tree/matrix

Breakout – Application of a risk decision tree

QRM Across the Product Lifecycle

Implementation of QRM from Design to Decommissioning

Conclusions/Summary

Take Back to Your Job

Summarize US, EU and WHO regulatory requirements, citations and expectations that may influence the implementation of a holistic QRM process

Understand the philosophy and application of a holistic lifecycle-based QRM process through the development of a Quality Risk Management Plan

Learn how to develop and implement a risk decision tree and the appropriate use of risk assessment tools

Understand the expected format of the risk management plan and file inclusive of risk ranking

Develop the ability to apply risk management methodologies throughout the product lifecycle

Understand best practices and lessons learned from implementing QRM and how to conduct effective risk assessments

Understand the Risk Based Approach for the Delivery of Facilities, Systems, Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

Understand how these documents align with the overall implementation of a robust QRM system that is applicable for the product lifecycle

Attendance Suggested For

Intermediate and management level Quality and Compliance Managers.

Intermediate practitioners of Commissioning and Qualification who want to understand and use QRM

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.

Group Discounts

3 - 5 participants - Save 10%

6 - 10 participants - Save 15%

11 or more participants - Save 20%

To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.